Family Wellness Antiseptic and Pain Relief

Product NDC: 69571-007
Requested package NDC: 69571-007-01
11-digit product format: 695710007
Labeler code: 69571
Product ID: 69571-007_08a19db8-4da9-6529-e063-6394a90a1b4d
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: FRONT PHARMACEUTICAL PLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-06-13
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: .51; .0035; 1; .01 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Family Wellness Antiseptic and Pain Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	.51 g/100g
NEOMYCIN SULFATE	.0035 g/100g
POLYMYXIN B SULFATE	1 g/100g
PRAMOXINE HYDROCHLORIDE	.01 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cb7fdcde-2bd8-4834-ba4e-4d6fd1512599	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69571-007-01	Family Wellness Antiseptic and Pain Relief	1 in 1 CARTON	OINTMENT	1		4
69571-007-01	Family Wellness Antiseptic and Pain Relief	28 g in 1 TUBE	OINTMENT	28		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69571-007	FAMILY WELLNESS ANTISEPTIC AND PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [FRONT PHARMACEUTICAL PLC]	4	Current NDC, Legacy NDC, 2 package rows	20231027_cb7fdcde-2bd8-4834-ba4e-4d6fd1512599.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Antiseptic and Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	FRONT PHARMACEUTICAL PLC	cb7fdcde-2bd8-4834-ba4e-4d6fd1512599	2023-10-26	Warnings	Exact identifier application number: M004 ndc (package): 69571-007-01 ndc (product): 69571-007 ndc11 (package): 69571000701
GENUINE FIRST AID Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	23abfe12-5b50-4b49-878e-4fcdb6c341fd	2023-10-19	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	f4921508-c32f-426f-a2f0-16c3acbd4713	2023-10-14	Warnings	Exact identifier application number: M004
Cuadriderma	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	ProMex LLC	4fa99b96-ab4b-4523-82bc-343dbaf39fb6	2022-01-25	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69571-007-01	69571000701	1 TUBE in 1 CARTON (69571-007-01) / 28 g in 1 TUBE	1 tube	2017-06-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Family Wellness Antiseptic and Pain Relief	FRONT PHARMACEUTICAL PLC	2023-10-26	HUMAN OTC DRUG LABEL	4